Replies to post #62197 on Biotech Values

[tinkershaw]

Dew, others,

What is your take on the appeal. I've only been able to go back and get a history of it, but my understanding is the present appeal is based upon the legal standard used in regard to burden of proof. The trial court used a burden shifting mechanism, whereas the defendant is arguing that it should be a totality of circumstances burden with no shifting of burden of proof as to intent.

Anyone looked at this issue in more detail. I'd be happy to look at the original appellate decision if anyone has the cite.

Tinker

[stockdak]

MNTA.
I would expect a bump to the low 20s with ANDA approval. If M118 is partnered as Wheeler hopes it will see 30s.

Case 1: 20%

I put in a small chance for this because I could be wrong about Case #2.

Case 2: 70%

Most likely because TEVA and Amphastar are getting the same guidance and IMO MNTAs tech. is not required to fulfill scientific issues for characterization of Lovenox generics.

Case 3: 10%

I put in a nominal % because the FDA OGD is overwhelmed.

Case 4: 0%

FDA seems to be telegraphing approval for the generics if hoops are jumped in correct fashion.